Bio-Techne Files Drug Master File With FDA For ExCellerate GMP IPSC Expansion Medium

RTTNews | vor 498 Tagen
Stocktwits
Bio-Techne Files Drug Master File With FDA For ExCellerate GMP IPSC Expansion Medium

(RTTNews) - Bio-Techne Corp. (TECH) announced Wednesday that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ExCellerate GMP iPSC Expansion Medium, Animal Free (CCM0036-GMP), supporting the development and manufacture of regenerative medicine and stem cell therapies.

ExCellerate GMP iPSC Expansion Medium is optimized to support robust expansion and maintenance of stem cell culture for enhanced consistency and reproducibility throughout the stem cell manufacturing process.

The GMP medium complements Bio-Techne's industry leading regenerative medicine therapy workflow solutions, which includes the widest range of GMP cytokines and growth factors available on the market.

The ready-to-use media is manufactured without the use of animal components and is available in preclinical and GMP grades to simplify transition from research to clinic.

The DMF submission provides the FDA with detailed information about the facilities and processes used in the manufacturing, processing, packaging, and storing of ExCellerate GMP iPSC Expansion Medium.

Regenerative medicine and stem cell therapy developers who integrate the medium into their GMP cell manufacturing workflows can easily reference these important details when filing Investigational New Drug (IND) applications with the FDA.

Tags: TECH
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Bio-Techne Q2 Results Miss Estimates; Declares Dividend

Bio-Techne Q2 Results Miss Estimates; Declares Dividend

Life sciences company Bio-Techne Corp. (TECH) reported Thursday that second-quarter net earnings attributable to the company almost halved to $27.47 million or $0.17 per share from $50.01 million or $0.31 per share in the prior-year quarter.
RTTNews | vor 455 Tagen
Bio-Techne To Acquire Namocell For Undisclosed Terms

Bio-Techne To Acquire Namocell For Undisclosed Terms

Life sciences company Bio-Techne Corp. (TECH) announced Wednesday it has reached an agreement to acquire Namocell, Inc., a provider of fast and easy to use single cell sorting and dispensing platforms that are gentle to cells, and preserve cell viability and integrity.
RTTNews | vor 1044 Tagen
UK Market Ends Slightly Up

UK Market Ends Slightly Up

On a day in which most of the markets across Europe remained closed for Labor Day holiday, the UK market, where trading was on, ended marginally up on Thursday, extending its gains to a 13th straight session.
RTTNews | vor 57 Minuten
Canadian Market Retreats After Recovering From Early Drop

Canadian Market Retreats After Recovering From Early Drop

The Canadian market is modestly higher around noon on Thursday with shares from energy and technology sectors posting strong gains. A sell-off in materials section is limiting market's upside. The mood in the market is quite cautious amid concerns about global economic growth.
RTTNews | vor 1Std 38 Minuten
U.S. Construction Spending Unexpectedly Falls 0.5% In March

U.S. Construction Spending Unexpectedly Falls 0.5% In March

Construction spending in the U.S. unexpectedly decreased in the month of March, the Commerce Department revealed in a report released on Thursday. The Commerce Department said construction spending fell by 0.5 percent to an annual rate of $2.196 trillion in March after climbing by 0.6 percent to a revised rate of $2.207 trillion in February.
RTTNews | vor 3Std 21 Minuten
U.S. Manufacturing Index Dips Slightly Further Into Contraction Territory In April

U.S. Manufacturing Index Dips Slightly Further Into Contraction Territory In April

The Institute for Supply Management released a report on Thursday showing a slight decrease by its reading on U.S. manufacturing activity in the month of April. The ISM said its manufacturing PMI edged down to 48.7 in April after slipping to 49.0 in March, with a reading below 50 indicating contraction. Economists had expected the index to dip to 48.0.
RTTNews | vor 3Std 34 Minuten
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